Regulatory Updates

Massage equipment and vibrating devices are commonly used for various purposes, but not all of them are classified as medical devices. The classification depends on their intended use and the claims made by the manufacturer. Here’s a breakdown of how these devices are classified according to the Medical Device Act

On May 20, 2024, the Ministry of Public Health of Thailand issued a notification regarding medical devices prohibited from direct sales or direct marketing under the law governing Direct Sales and Direct Marketing. By Section 5, Paragraph One, and Section 6 (12) of the Medical Device Act B.E. 2551 (2008),

The Minister of Public Health, upon the advice of the Medical Device Committee, established the criteria and methods for the transportation, storage, destruction, or disposal of medical devices under the Authority conferred by Section 5, Paragraph One, and Section 6 (16) of the Medical Device Act B.E. 2551 (2008). Under

The Secretary-General of the Food and Drug Administration hereby issues the draft announcement as follows: Section 1: This Announcement shall be effective from the day following its publication in the Government Gazette. Section 2: Guidelines for submitting applications for medical device advertising that requires academic document evaluation are as follows:

Following the authority conferred by Section 5(1) of the Medical Device Act B.E. 2551 (2008) and Section 41(7) as amended by the Medical Device Act (No. 2) B.E. 2562 (2019), the Minister of Public Health hereby issues the following announcement: The registrant shall prepare signage to display the supervisor’s name

On May 20, 2024, the Ministry of Public Health of Thailand issued a notification governing medical devices that require Supervisors for Control of Production, Import, or Sale and the qualifications, number, and duties of such supervisors, B.E. 2567 (2024). Medical device operators must appoint at least one supervisor with qualifications